Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children

Centre Hospitalier Universitaire Saint Pierre1,362 enrolled

Overview

This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother. In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured. Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Study Type

OBSERVATIONAL

Enrollment

1,362

Conditions

Pregnancy Covid-19

Interventions

no interventionOTHER

no intervention

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * For pregnant women, all women who deliver in the CHU St Pierre, with oral consent. * For children follow up: children born to positive mothers and matched controls after written consent Exclusion Criteria: * none

Locations (1)

CHU SAINT Pierre

Brussels, Belgium

Outcomes

Primary Outcomes

Outcome of pregnancy

Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis

Time frame: Up to the delivery

Secondary Outcomes

Prevalence of positive serology to SARS-CoV-2 at delivery

Measure of antibodies in maternal serum at delivery

Time frame: At the delivery

Transplacental transfer of antibodies to SARS-CoV-2

Measure the ratio of cord blood antibodies on maternal antibodies titers

Time frame: At the delivery

To characterize placental alterations related to SARS-CoV-2 infection

Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy

Time frame: At the delivery

Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers

Time frame: At 1 month post delivery

To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life

Measure of antibodies in cord blood and at the age of 1 month

Time frame: Up to 1 month post delivery

Clinical evolution of the children

Occurence of infectious disease, neurological development, growth

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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